Heat Wrap Device Safety With Age and Body Fat

Back Pain Clinical Trial

Official title:

An Open Label Study To Compare The Effects Of Age And Body Fat On The Safety Of Two Heat Wrap Devices In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01355653
• Other study ID #: B3571002
• Secondary ID: TC-09-12
• Status: Completed
• Phase: N/A
• First received: April 28, 2011
• Last updated: August 26, 2011
• Start date: April 2011
• Est. completion date: July 2011

Study information

• Verified date: August 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is designed to compare the safety, as measured by skin findings and adverse events, of two different heat devices in elderly, overweight, and elderly and overweight subjects.

Description:

Safety measurements

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 84 Years

Eligibility

Inclusion Criteria:

• Males or females in generally good health, and who are either 18-54 years of age with a body mass index of = 30 kg/m2

• or 55-84 years of age and with a body mass index = 30 kg/m2 or < 30 kg/m2

• Females who are not pregnant or breastfeeding

• Subject is medically cleared for study participation

Exclusion Criteria:

• No sensitivity or allergy to device components in contact with skin

• Diabetes

• Any active skin disease or tattoos at the test site that would affect participation

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Back Pain

Intervention

Device:
• thermal therapy
heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day
• marketed heatwrap
heatwrap, topical, one time application, 8 hour duration

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects with any thermal-related skin events (defined as elevated skin response, erythema = 2.0 [moderate], or pain upon touch plus non-zero erythema)		morning after product wear through 15 days after last product application	Yes
Secondary	Percentage of subjects with any adverse event		during and after wear for 28 days after last wear	Yes

External Links

•   To obtain contact information for a study center near you, click here.